Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000083796
Ethics application status
Approved
Date submitted
16/12/2021
Date registered
21/01/2022
Date last updated
27/05/2024
Date data sharing statement initially provided
21/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Medicinal Cannabis for managing distressing symptoms in cancer patients.
Scientific title
Medicinal Cannabis (MedCan 3) – a randomised, multicentre, double blind, placebo-controlled trial to assess THC/CBD (1:20) to relieve symptom burden in patients with cancer
Secondary ID [1] 306064 0
Nil Known
Universal Trial Number (UTN)
NIL
Trial acronym
MedCan 3 – THC/CBD (1:20)
Linked study record
NIL

Health condition
Health condition(s) or problem(s) studied:
Cancer 324712 0
Condition category
Condition code
Cancer 322160 322160 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 – THC/CBD (Delta-9-tetrahydrocannabinol/cannabidiol) 10mg/200mg/mL oral solution (dose range 2.5mg/50mg-30mg/600mg/day)
Dosing commences as per the dosing schedule at 0.25mls daily, increasing every 2 days for 14 days reaching a max dose of 1ml three times per day. The day 14 dose can then be continues for days 15-28. If the participant experiences unwanted adverse effects the dose can be reduced back to the previously tolerated level. The dose can also be stabilised when effectiveness is reached prior to day 14 if applicable.
Study drug must be brought in to each study visit to monitor compliance.
Intervention code [1] 322472 0
Treatment: Drugs
Comparator / control treatment
Arm 2 – Placebo oral solution identical in appearance and taste matched to the active product.

Avocado Oil
Rosemary Oleoresin
Sage Oil
Walnut Oil (cold pressed)
Medium Chain Triglycerides Oil
Control group
Placebo

Outcomes
Primary outcome [1] 329930 0
The change from baseline of total symptom distress score (TSDS) as measured by the Edmonton Symptom Assessment Scale (ESAS) at day 14.
Timepoint [1] 329930 0
Baseline,
14 days post the commencement of the intervention.
Secondary outcome [1] 404323 0
Patient determined effective dose of THC/CBD formulation, (the dose that achieves symptom relief with acceptable side-effects) (TSDS ESAS). Medication schedule records daily doses. This is completed by the participant at home and also noted by the research staff during phone call assessments and clinic visits.
Timepoint [1] 404323 0
28 days after intervention starts.
Secondary outcome [2] 404325 0
Change from baseline in Total Symptom Distress Score on the Edmonton Symptom Assessment System (ESAS).
Timepoint [2] 404325 0
At Baseline, 7, 14,21, and 28 days post intervention commencement.
Secondary outcome [3] 404326 0
Change from baseline in individual ESAS scores.
Timepoint [3] 404326 0
Baseline, Day 7, 14, 21, 28 post commencement of the intervention.
Secondary outcome [4] 404327 0
Global Impression of Change scores (CGI) (patient and investigator rated).
Timepoint [4] 404327 0
Days 7, 14, 21, 28 post commencement of the study intervention.,
Secondary outcome [5] 404328 0
Change from baseline in The Depression, Anxiety and Stress Scale – 21 Items (DASS – 21).
Timepoint [5] 404328 0
Baseline, Days 7, 14, 21, 28 post commencement of study intervention.
Secondary outcome [6] 404329 0
change from baseline in opioid use using oral morphine equivalents (OME). Assessed by the researchers at clinic visits based on previous 24hours opioid use as reported by the participant and the comedications document.
Timepoint [6] 404329 0
Baseline, Days 7, 14, 21, 28 post commencement of study intervention.
Secondary outcome [7] 404330 0
Change from baseline in Quality of Life scores (EORTC QLQ-C15-PAL)
Timepoint [7] 404330 0
Baseline, Days 14 and 28 post commencement of intervention.
Secondary outcome [8] 404332 0
To document adverse events associated with MC use using the National Cancer Institute, Common Terminology Criteria for Adverse Events. V4.0 (NCI, CTCAE V4.0).
Timepoint [8] 404332 0
Baseline, Day 2, 4, 7, 9, 11, 14, 21, 28 post study intervention commencement.
Secondary outcome [9] 404333 0
Change from baseline in total Insomnia Severity Index (ISI).
Timepoint [9] 404333 0
Baseline, Day 7 and 14 post commencement of the intervention.
Secondary outcome [10] 404334 0
Change from baseline in Sleep score on Numerical Rating Scale (NRS).
Timepoint [10] 404334 0
Baseline, Days 7, 14, 21, 28 post commencement of the study intervention.
Secondary outcome [11] 404335 0
Objective measure of sleep via Actigraphy. These measures will include - Total Sleep Time, Sleep Efficiency, Wake After Sleep Onset, and Sleep Onset Latency (min) compared to baseline.
Timepoint [11] 404335 0
Baseline, Days 1-14 post commencement of study intervention.
Secondary outcome [12] 428946 0
Change in C-reactive protein (CRP) measures using serum samples.
Timepoint [12] 428946 0
Baseline, Day 14, and Day 28, post commencement of the study intervention.
Secondary outcome [13] 428947 0
Change from baseline in haematology (FBC) & biochemistry (e/LFT) measures using serum samples.
Timepoint [13] 428947 0
Baseline, Day 14, and Day 28, post commencement of the study intervention.
Secondary outcome [14] 428948 0
Change from baseline in haematology (FBC) & biochemistry (e/LFT) measures using serum samples.
Timepoint [14] 428948 0
Baseline, Day 14, and Day28 post commencement of the trial intervention.
Secondary outcome [15] 428949 0
Change from baseline in AKPS & RUG ADL. using clinical assessment tool.
Timepoint [15] 428949 0
Baseline, Day 14, and Day28 post commencement of the trial intervention.
Secondary outcome [16] 428950 0
Change from baseline in AKPS & RUG ADL. using clinical assessment tool.
Timepoint [16] 428950 0
Baseline, Day 7, Day 14, Day 21, and Day 28, post commencement of the trial intervention.
Secondary outcome [17] 428951 0
Concurrent medication use, collected from the medical records.
Timepoint [17] 428951 0
Baseline, Day 7, Day 14, Day 21, and Day 28, post commencement of the trial intervention.
Secondary outcome [18] 428952 0
Concurrent medication use, collected from the medical records.
Timepoint [18] 428952 0
Baseline, Day 7, Day 14, Day 21, and Day 28 post commencement of trial intervention.
Secondary outcome [19] 428953 0
ASSIST scores at eligibility using a clinical assessment tool.
Timepoint [19] 428953 0
Baseline, Day 7, Day 14, Day 21, and Day 28 post commencement of trial intervention.
Secondary outcome [20] 428954 0
ASSIST scores at eligibility using a clinical assessment tool.
Timepoint [20] 428954 0
Eligibility
Secondary outcome [21] 428955 0
Cognitive assessment (SLUMS) at eligibility, using a clinical assessment tool.
Timepoint [21] 428955 0
Eligibility
Secondary outcome [22] 428956 0
Cognitive assessment (SLUMS) at eligibility, using a clinical assessment tool.
Timepoint [22] 428956 0
Eligibility.
Secondary outcome [23] 428957 0
Disease progression as assessed by the clinician researcher.
Timepoint [23] 428957 0
Eligibility.
Secondary outcome [24] 428958 0
Disease progression as assessed by the clinician researcher.
Timepoint [24] 428958 0
Day 14 and Day 28 post intervention commencement.
Secondary outcome [25] 428959 0
Overall survival. Collected direct from the medical records.
Timepoint [25] 428959 0
Day 14 and Day 28 post intervention commencement.
Secondary outcome [26] 428960 0
Overall survival. Collected direct from the medical records.
Timepoint [26] 428960 0
On completion of the study data collection period.
Secondary outcome [27] 428961 0
Polymorphisms in the candidate genes CNR1, CNR2, ABCB1 and OPRM1 using DNA samples.
Timepoint [27] 428961 0
On completion of the study data collection period.
Secondary outcome [28] 428962 0
Polymorphisms in the candidate genes CNR1, CNR2, ABCB1 and OPRM1 using DNA samples.
Timepoint [28] 428962 0
Once only blood test during the study period.

Eligibility
Key inclusion criteria
Patients with advanced histologically proven cancer (metastatic or locally advanced) known to the palliative care team of the recruiting centre who:
-have an ESAS TSDS of 10 of higher for cancer-related symptoms*, and at least one individual ESAS score of 3 or higher (for sleep component need to have a sleep NRS score of 3 or higher)
-a Performance Status AKPS (Australia-modified Karnofsky Scale score) of at least 30
-are aged 18 years or older, English-speaking (or have an interpreter available)
-have a negative pregnancy urine test at eligibility (only if of reproductive potential) and agree to avoid pregnancy during the study and 12 weeks following the last dose of the study drug. Males must agree to avoid fathering a child and to not donate sperm during the study and for at least 12 weeks following the last dose of the study drug
-have a negative THC urine test at eligibility for previous cannabinoid use
-are able to tolerate oral medications
-are willing to receive standard palliative care as delivered by their primary treating team
-can comply with all trial requirements: agree to attend scheduled clinic appointments, adhere to dose titration schedules as directed
-agree to use no other cannabis based products for the duration of the trial
-understand that it is illegal to drive whilst taking THC containing cannabis products, to take cannabinoid products outside of Australia or to endorse legal documents whilst taking THC containing cannabis products.
• are able to provide fully informed consent
* physician assessed
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with:
-a history of hypersensitivity to any cannabinoid
-unstable, untreated cardiovascular disease (hypertension, ischaemic heart disease, congestive cardiac failure)
-severe hepatic impairment (total bilirubin of 1.5 times or greater than the upper limit of the institution’s normal range, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 3.0 times or greater than the upper limit of the institution’s normal range. Subjects with liver metastasis may have an AST and ALT of up to 5.0 times the upper limit of normal)
-severe renal impairment (eGFR of 20mL/min/1.73m2 or greater)
-known allergy to nuts, coconut, avocado, sage or rosemary
-a history of psychosis, schizophrenia or severe mood disorders
-cognitive impairment (SLUMS - St Louis University Mental Status) examination equal to or less than 20/30.
-known substance use disorder (ASSIST - Alcohol, Smoking and Substance Involvement Screening Test) examination scoring greater than 27 for any substance
-history suggesting that drug diversion may be a risk for them or their family/carers
-females who are pregnant or lactating
-concurrent or participation in a trial of a new clinical entity within the last 28 days
-treatment with a new specific anticancer agent (chemotherapy, targeted or hormonal therapy) or radiation within the last 7 days

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contacting the holder of the allocation schedule using a central trials pharmacy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
a 1:1 randomisation scheme and a Type 1 error of 5% (two-tailed), and a standard deviation of 11.6 - computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size for the primary outcome is based on previous work by Hui et al., who determined that the minimal clinically important difference in the TSDS to be 5.7. As such we estimated a sample size to detect an improvement of 6 or greater in the TSDS as the primary outcome measure. Allowing 20% for attrition, and with improvement of 6 for Arm 1 compared to placebo, it is anticipated that 150 participants (75 per arm) should be randomized to achieve a sample size of 60 participants per arm, assuming 80% power, a 1:1 randomisation scheme and a Type 1 error of 5% (two-tailed), and a standard deviation of 11.6.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/04/2022
Actual
14/12/2022
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
30/05/2025
Actual
Sample size
Target
150
Accrual to date
35
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21348 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [2] 21349 0
Mater Private Hospital - South Brisbane
Recruitment hospital [3] 21350 0
Mater Private Hospital Redland - Cleveland
Recruitment hospital [4] 21351 0
St Vincent's Hospital Brisbane - Kangaroo Point
Recruitment hospital [5] 26595 0
Mater Private Hospital Springfield - Springfield Central
Recruitment postcode(s) [1] 36239 0
4101 - South Brisbane
Recruitment postcode(s) [2] 36240 0
4163 - Cleveland
Recruitment postcode(s) [3] 36241 0
4169 - Kangaroo Point
Recruitment postcode(s) [4] 42638 0
4300 - Springfield Central

Funding & Sponsors
Funding source category [1] 310400 0
Government body
Name [1] 310400 0
National Health and Medical Research Council
Country [1] 310400 0
Australia
Primary sponsor type
Hospital
Name
Mater Misericordiae Ltd
Address
Mater Misericordiae Ltd
Aubigny Place,
Raymond Terrace,
South Brisbane, Qld, 4101
Country
Australia
Secondary sponsor category [1] 311554 0
None
Name [1] 311554 0
Address [1] 311554 0
Country [1] 311554 0
Other collaborator category [1] 282091 0
University
Name [1] 282091 0
The University of Queensland
Address [1] 282091 0
St Lucia, Qld, 4072.
Country [1] 282091 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310050 0
Mater Misericordiae Ltd Human Research Ethics Committee (EC00332)
Ethics committee address [1] 310050 0
Ethics committee country [1] 310050 0
Australia
Date submitted for ethics approval [1] 310050 0
26/11/2021
Approval date [1] 310050 0
24/01/2022
Ethics approval number [1] 310050 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116310 0
Prof Phillip Good
Address 116310 0
Mater Misericordiae Ltd
Palliative and Supportive Care Research
Aubigny Place,
Raymond Tce, South Brisbane, Qld, 4101
Country 116310 0
Australia
Phone 116310 0
+61 073163 3884
Fax 116310 0
Email 116310 0
[email protected]
Contact person for public queries
Name 116311 0
Karyn Foster
Address 116311 0
Mater Misericordiae Ltd
Palliative and Supportive Care Research
Aubigny Place,
Raymond Tce, South Brisbane, Qld, 4101
Country 116311 0
Australia
Phone 116311 0
+61 073163 3884
Fax 116311 0
Email 116311 0
[email protected]
Contact person for scientific queries
Name 116312 0
Phillip Good
Address 116312 0
Mater Misericordiae Ltd
Palliative and Supportive Care Research
Aubigny Place,
Raymond Tce, South Brisbane, Qld, 4101
Country 116312 0
Australia
Phone 116312 0
+61 073163 3884
Fax 116312 0
Email 116312 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD will be uploaded/shared on accessible databases. Data will be available upon request by journals/publications.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.